NCT07132203

Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases Trial

A Multicenter Trial for the Safety and Efficacy of a Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In accordance with the requirements of the "Good Clinical Practice for Medical Devices", this clinical trial is conducted to further evaluate the safety and efficacy of the magnetic resonance-guided laser ablation treatment system and the laser ablation minimally invasive treatment kit produced by Sinovation (Beijing) Medical Technology. This clinical trial adopts a multi-center, single-groupdesign. After all subjects sign the informed consent form and pass the screening, they will receive the implantation and treatment of the trial products. Follow-up visits will be conducted on the 2±1 day after the surgery, and the efficacy rate of ablation as assessed after the surgery was used as the primary outcome.

Conditions

• Brain Metastasases

Interventions

Type	Name	Description
DEVICE	Laser interstitial thermal therapy	The LITT procedure was performed using the LS1 laser ablation system and SR1 stereotactic robotic system (Sinovation, Beijing, China). The ablation system was equipped with a 980-nm laser with a maximum of 15 W of power, a core silica fiber optic with a 1.8-mm diameter cooling catheter, and a cooling pump to make saline flow into and out through the catheter. The optic and catheter approaches were planned with the preoperative simulation software (Sinovation, Beijing, China) using the preoperative T1-weighted MRI scan, and passing through important cerebral vascular and functional zones was avoided。. The catheter was implanted by neurosurgeons under stereotactic guidance, and a laser probe was inserted through the catheter. After LITT, a T1-weighted intraoperative MRI scan was performed to confirm the effect of ablation. The ablation rate was calculated by another neurosurgeon who did not participate in the study.

Timeline

• Start date: 2022-01-11
• Primary completion: 2025-02-20
• Completion: 2025-06-11
• First posted: 2025-08-20
• Last updated: 2025-08-20

Locations

6 sites across 1 country: China